FDA.reportPublic FDA data

TriniLIA™ D-Dimer Saline

Primary DI
15391521420760
Brand
TriniLIA™ D-Dimer Saline
Company
TCOAG IRELAND LIMITED
Model
T3000
Published
2016-09-12
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GHHFibrin Split Products

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GHHFibrin Split ProductsHematology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15391521420760PrimaryGS10
05391521420763Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1539152142076015391521420760
05391521420763053915214207635391521420763

GMDN Terms#

Term, Definition table
TermDefinition
D-dimer IVD, kit, agglutinationA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of D-dimer protein in a clinical specimen, using an agglutination method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
985039126
Device count
5
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
15391521420630TriniCHECK Level 1T41112019-06-28
15391521420647TriniCHECK Level 2T41122019-06-28
15391521420654TriniCHECK Level 3T41132019-06-28
15391521420708TriniCAL™ Reference PlasmaT51022016-09-12
15391521421101TriniCHECK™ Abnormal controlT41042016-09-12
05391521420718TriniVerical™ T51032016-09-12
05391521420534TriniCHROM™ Antithrombin IIaT26022016-09-12
15391521420234TriniCLOT™ PT HTF 20 mLT11012016-09-12
15391521420241TriniCLOT™ PT HTF 6 mLT11022016-09-12
15391521420340TriniCLOT™ Automated aPTT 3 mLT12062016-09-12
15391521420661TriniCHECK™ Lupus Positive ControlT42032016-09-12
15391521420777TriniCHECK™ D-Dimer 1T43032016-09-12
15391521421125Destiny System FluidDSF2016-09-12
05391521420282TriniCLOT™ PT Excel 6 mLT11062016-09-12
05391521420305TriniCLOT™ aPTT S 3 mLT12022016-09-12
05391521420541TriniCHROM™ Antithrombin XaT26032016-09-12
05391521421029Destiny PlusH01000P2016-09-12
05391521421081Destiny MAX AnalyzerM010002016-09-12
15391521421309DT WashDTW2019-06-28
15391521421729DT FluidDTF2019-06-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613336133651Tina-quant D-DimerRoche Diagnostics GmbHGHH2020-12-04
00817089020528DiazymeDIAZYME LABORATORIES, INC.GHH2016-11-03
00817089020535DiazymeDIAZYME LABORATORIES, INC.GHH2016-11-03
00817089020542DiazymeDIAZYME LABORATORIES, INC.GHH2016-11-03
15099590000332AUBeckman Coulter, Inc.GHH2016-09-24
15099590070588AUBeckman Coulter, Inc.GHH2016-09-24
15099590080884AUBeckman Coulter, Inc.GHH2016-09-24
04987595301537PATHFAST D-DimerPHC CORPORATIONGHH2016-09-22
04015630900091Tina-quant D-DimerRoche Diagnostics GmbHGHH2016-09-20
04015630914593Tina-quant D-DimerRoche Diagnostics GmbHGHH2016-09-20
00845275000863Thermo Scientific Pacific Hemostasis®Fisher DiagnosticsGHH2016-09-16
00845275000870Thermo Scientific Pacific Hemostasis®Fisher DiagnosticsGHH2016-09-16
00845275000887Thermo Scientific Pacific Hemostasis®Fisher DiagnosticsGHH2016-09-16
00845275000894Thermo Scientific Pacific Hemostasis®Fisher DiagnosticsGHH2016-09-16
00845275000900Thermo Scientific Pacific Hemostasis®Fisher DiagnosticsGHH2016-09-16
00816426020368K-ASSAY® D-Dimer ReagentKAMIYA BIOMEDICAL COMPANY, LLCGHH2016-09-16
00816426020665K-ASSAY® D-Dimer CalibratorKAMIYA BIOMEDICAL COMPANY, LLCGHH2016-09-16
03607450004540D-Di Test®DIAGNOSTICA STAGOGHH2016-09-15